Documents and
Records
1
Learning Objectives
At the conclusion of this session, you will be able
to:
 explain the difference between documents and
records;
 describe the hierarchy of documents and the
role of each level;
 outline the contents of a quality manual;
 outline the content that should be included in a
standard operating procedure;
 explain the important steps, or elements, of a
laboratory document management system;
 describe methods and tools to properly store
documents and records.
Documents and Records - Module 16
2
Scenario
You have found all these papers lying on a desk.
Which of these are documents and which are
records?






testing algorithm
safety manual
client test results
standard operation
procedures (SOPs) for an
approved HIV rapid test
manufacturer test kit
inserts
summary of findings from
on-site evaluation visit
Documents and Records - Module 16






report of corrective actions
temperature log (blank
form)
quality control record (blank
form)
daily maintenance log
(completed)
stock cards and stock book
(completed)
EQA specimen transfer log
(completed)
3
The Quality Management System
Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Documents and Records - Module 16
Facilities
&
Safety
4
Why do laboratories need to manage
documents and records?
To find information
whenever it is needed!
Documents and Records - Module 16
5
Documents and Records—How do they differ?
Documents
 communicate
information via
policies, processes,
and procedures
 need updating
Records
 capture information
on worksheets,
forms, labels, and
charts
 permanent, do not
change
RECORDS
Documents and Records - Module 16
6
Information is the
major product
of the laboratory
Documents and Records - Module 16
7
Policies
Laboratory
Documents
Procedures
Documents and Records - Module 16
Processes
8
Policies - The “WHAT TO DO”
“A written statement of overall intentions
and directions defined by those in the
organization and endorsed by
management.” (CLSI HS1-A3)
Policies:
 tell “what to do” in a broad and general way
 include the organizational mission, goals, and
purpose
 serve as the framework for the quality system
 should always be specified in the quality
manual
Documents and Records - Module 16
9
Processes - The “HOW IT HAPPENS”
A “set of interrelated or interacting
activities that transform inputs into
outputs.” (ISO 9000 4.3.1)
Processes:
 describe the steps involved to carry
out quality policies
 easily represented in flow charts
 involve a series of steps, usually
occurring over a period of time
Documents and Records - Module 16
10
Procedures - The “HOW TO DO IT”
Standard operating procedures (SOP)
 step-by-step instructions for
performing a single activity
Job aid
 a shortened version of the SOP
 does not replace the SOP
Documents and Records - Module 16
11
Hierarchy of Documents
“How to do it”
“How it happens”
“What to do”
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12
Why are documents important?

essential guidelines for laboratory
 quality manual
 SOPs
 reference materials

required by formal laboratory standards
Documents and Records - Module 16
13
Documents are the communicators
of the quality management system
Verbal instructions often are:
not heard
 misunderstood
 quickly forgotten
 difficult to follow

Documents and Records - Module 16
14
Documents are a reflection of
the laboratory’s organization
and its quality management.
A good rule to follow is:
“Do what you wrote and
write what you are doing.”
Documents and Records - Module 16
15
Good Documents are:

clear

concise

user-friendly

explicit

accurate

up-to-date
Documents and Records - Module 16
16
Documents for work processes should
be accessible to staff at the work site :
 instructions
on handling incoming samples
 SOPs for each test
 quality control charts
and trouble-shooting
instructions
 safety manuals
and precautions
Documents and Records - Module 16
17
The Quality Manual
is a document describing the
quality management system
of an organization
(ISO 15189)
Documents and Records - Module 16
18
Quality Manual
communicates information
 serves as a framework or roadmap
for meeting quality management
system requirements
 demonstrates management
commitment to quality

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19
Writing a Quality Manual
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20
Writing a Quality Manual
Form a Steering Committee
Describe how
the related
quality
processes occur
Reference
procedures
Documents and Records - Module 16
21
Key Points: Quality Manual
only ONE official version
 never “done”, always being improved
 read and accepted by everyone
 use the best-adapted language

Very big job, but very useful
Documents and Records - Module 16
22
Standard Operating Procedures
(SOPs) are documents that:
 describe how to perform a test
using step-by-step instructions
 written SOPs help ensure:
consistency
accuracy
quality
Documents and Records - Module 16
23
A Good SOP
provides detailed, clear, and concise
direction for testing techniques
 is easily understood by new
personnel
 is reviewed and approved by
management
 is updated on a regular basis

Documents and Records - Module 16
24
Standardized SOP Format

J Johnson,
RB Smith

Computerized procedure
Standardization:







Documents and Records - Module 16
Header
Version/chapter/reference
Author/reader/validator
Recipients
Version date/Application
date
Typical outline
Updating and storage of
different versions is easy
25
Complete Standardized Header
Use at the top of the first page only
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26
Reduced Standardized Header

other pages of every procedure

use at the top of all other pages
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27
When Preparing SOPs
determine
procedure
to use
establish
means for
updating
gather all
documents
Documents and Records - Module 16
assess
scientific
validity
include
each step
28
Suggested Outline for SOPs






Title: Name of Test
Purpose: Medical use
Instructions:
 Preexamination
 Examination
 Postexamination
References to verify the method is
established
Author’s name
Approval signature(s)–initial and date
Documents and Records - Module 16
29
Avoid Drowning in Detail…..

BAD EXAMPLE: “The purpose
of this procedure is to
document the
aforementioned activities,
herin after referred to as the
prescribed tasks in terms
that preclude their execution
in an inconsistent manner,
wherin such inconsistency
may potentially result in the
prescribed tasks delivering a
result that is not repeatable
or reproducible”…
Documents and Records - Module 16
30
Do not rely solely on manufacturer
product inserts
Inserts do not provide specific
information for test sites,
such as:

materials required, but not in kit

specific safety requirements

external quality control requirements
Documents and Records - Module 16
31
Job Aids
shortened version of SOPs
 hand written or printed
 visible location at testing site
 useful tool to assure all testing steps
are correctly performed

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32
Job Aids
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33
Job Aids
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34
Document Control
assures that the
most current
version is used
ensures availability
when needed
organizational tool
Documents and Records - Module 16
35
Document Control Elements
system for organizing, such as
numbering or coding system
 approval, distribution, and revision
process
 master log that describes which
documents are in circulation
 accessibility of documents at the
point of use
 system for archiving

Documents and Records - Module 16
36
regulations
and
standards
SOPs
Controlled
documents
equipment
service
manuals
Documents and Records - Module 16
texts,
articles,
reference
books
37
Documents of External Origin

Include in the laboratory document
control system:
 instrument
service manuals
 industry regulations
 ISO standards
 references used for documentation
Documents and Records - Module 16
38
Numbering System





need uniform numbering system
do not change a current system that works
one system: letter for the type of document
and then an incremented number: B1, B2,
B3 for books and T1, T2 for official texts
number all pages of document
reference by document code, pages,
location code: Book number 2, pages 188200, on bookshelf 1: B2,188-200, BS1
Documents and Records - Module 16
39
Document Preparation and
Control Process
Preparation
Issue
Distribution
Review
Revision
Documents and Records - Module 16
Approval
40
Implementing Document Control
collect existing documents and
records
 review and update
 determine additional needs
 develop or obtain documents, forms,
worksheets, logbooks, reports
 involve stakeholders

Documents and Records - Module 16
41
Common Document Control Problems
outdated documents
 too many documents are
distributed and the system
cannot be maintained
 lack of control of documents
of external and internal origin

Documents and Records - Module 16
42
Why are records essential?
Continuous
monitoring
of
quality
system
Management
tool
Documents and Records - Module 16
Sample
tracking
throughout
process
Identify
problems
43
Sample
log book
or register
Patient
test reports
Workbooks
Worksheets
Laboratory
Records
EQA /
PT records
Quality
control
data
Documents and Records - Module 16
Instrument
printouts
Maintenance
records
44
Personnel
records
Critical
communications
Internal
audits
results
More
Records
Customer
feedback
User
surveys
Documents and Records - Module 16
External
audits
results
Continuous
improvement
45
Keep the Things You Might
Forget!





disposition of rejected samples
referral of samples to another
laboratory
records of adverse occurrences or
problems
inventory and storage records
equipment purchase data,
preventive maintenance, and
troubleshooting
Documents and Records - Module 16
46
Test Report Contents ISO 15189








test identification
laboratory identification 
patient unique

identification and location
name and address of

requestor

date and time of
collection
time of receipt in lab
date and time of release 
of report
Documents and Records - Module 16
primary sample type
results (SI units)
biological reference
intervals
interpretive comments
person authorizing
release, with signature
when possible
note if reporting a
corrected result
47
Paper Systems
 Permanence

Security
 maintain
confidentiality
 keep safe from
environmental
hazards

Traceability
 allow for tracking of a
specimen throughout
all processes
 bind
books
 number pages
 use permanent ink
 control storage

Accessibility
 use system that will
allow ease of access
Documents and Records - Module 16
48
Documents and Records - Module 16
49
Electronic Systems

permanence
 computer

system maintenance, backups
security
 access
 confidentiality

traceability
Documents and Records - Module 16
50
National
legislation
and
regulation
Testing
process
review
Factors
affecting
retention
times
Research
purposes
Time
between
assessments
-audits
Documents and Records - Module 16
51
Summary
Documents:

include written policies, processes, and procedures

need to be updated and maintained
Records:

include information captured in processes

are permanent, do not require updating
A good document control program:

most current version used

availability and ease of access
Documents and Records - Module 16
52
Key Messages

Information is our product.

Documents are essential for assuring
accuracy and consistency in the
laboratory.
Documents and Records - Module 16
53
Scenario
You have found all these papers lying on a desk.
Which of these are documents and which are
records?






testing algorithm
safety manual
client test results
standard operation
procedures (SOPs) for an
approved HIV rapid test
manufacturer test kit
inserts
summary of findings from
on-site evaluation visit
Documents and Records - Module 16






report of corrective actions
temperature log (blank
form)
quality control record (blank
form)
daily maintenance log
(completed)
stock cards and stock book
(completed)
EQA sample transfer log
(completed)
54
Scenario
You have found all these papers lying on a desk.
Which of these are documents and which are
records?






testing algorithm
safety manual
client test results
standard operation
procedures (SOPs) for an
approved HIV rapid test
manufacturer test kit
inserts
summary of findings from
on-site evaluation visit
Documents and Records - Module 16






report of corrective actions
temperature log (blank
form)
quality control record (blank
form)
daily maintenance log
(completed)
stock cards and stock book
(completed)
EQA sample transfer log
(completed)
55
Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Questions?
Comments?
Documents
&
Records
Occurrence
Management
Process
Improvement
Customer
Service
Documents and Records - Module 16
Assessment
Facilities
&
Safety
56